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Glatiramer Acetate (Glatiramer Acetate)

Trade Name : Glatiramer Acetate

Mylan Pharmaceuticals Inc.

INJECTION, SOLUTION

Strength 20 mg/mL

GLATIRAMER ACETATE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glatiramer Acetate (Glatiramer Acetate) which is also known as Glatiramer Acetate and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 20 mg/mL per ml. Read more

Glatiramer Acetate (Glatiramer Acetate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Indications and Usage ()u00a0u00a0u00a0u00a0u00a07/2019
  • Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
  • Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ().
  • No data
  • No data
  • u2022
  • 3
  • Glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
  • Known hypersensitivity to glatiramer acetate or mannitol ()
  • No data
  • The following serious adverse reactions are described elsewhere in the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Interactions between glatiramer acetate and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of glatiramer acetate with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. Glatiramer acetate has not been formally evaluated in combination with interferon beta.
  • No data
  • Glatiramer acetate, the active ingredient of glatiramer acetate injection, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 u2013 9,000 daltons. Glatiramer acetate is identified by specific antibodies.
  • Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:
  • (Glu, Ala, Lys, Tyr)n n CHCOOH (CHNOn CHNOn CHNOn CHNO)n n CHOn CAS - 147245-92-9
  • Glatiramer acetate is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of glatiramer acetate solution contains 20 mg of glatiramer acetate and the following inactive ingredient: 40 mg of mannitol. The pH of the solutions is approximately 5.5 to 7.0. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.
  • No data
  • Carcinogenesis
  • In a 2-year carcinogenicity study, mice were administered up to 60 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose of 20 mg/day on a mg/mbasis). No increase in systemic neoplasms was observed. In males receiving the 60-mg/kg/day dose, there was an increased incidence of fibrosarcomas at the injection sites. These sarcomas were associated with skin damage precipitated by repetitive injections of an irritant over a limited skin area.
  • In a 2-year carcinogenicity study, rats were administered up to 30 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose on a mg/mbasis). No increase in neoplasms was observed.
  • Mutagenesis
  • Glatiramer acetate was not mutagenic in (Ames test, mouse lymphoma tk) assays. Glatiramer acetate was clastogenic in two separate chromosomal aberration assays in cultured human lymphocytes but not clastogenic in an mouse bone marrow micronucleus assay.
  • Impairment of Fertility
  • When glatiramer acetate was administered by subcutaneous injection prior to and during mating (males and females) and throughout gestation and lactation (females) at doses up to 36 mg/kg/day (18 times the human therapeutic dose on a mg/m basis) no adverse effects were observed on reproductive or developmental parameters.
  • Evidence supporting the effectiveness of glatiramer acetate derives from five placebo-controlled trials, four of which used a glatiramer acetate injection dose of 20 mg per mL per day and one of which used a glatiramer acetate injection dose of 40 mg per mL three times per week.
  • Arrayn- Glatiramer Acetate Injection 20 mg per mL per day:
  • Patients were examined every 3 months for 2 years, as well as within several days of a presumed exacerbation. To confirm an exacerbation, a blinded neurologist had to document objective neurologic signs, as well as document the existence of other criteria (e.g., the persistence of the neurological signs for at least 48 hours).
  • The protocol-specified primary outcome measure was the proportion of patients in each treatment group who remained exacerbation free for the 2 years of the trial, but two other important outcomes were also specified as endpoints: the frequency of attacks during the trial, and the change in the number of attacks compared with the number which occurred during the previous 2 years.
  • Table 3 presents the values of the three outcomes described above, as well as several protocol-specified secondary measures. These values are based on the intent-to-treat population (i.e., all patients who received at least 1 dose of treatment and who had at least 1 on-treatment assessment):
  • Study 2 was a multicenter trial of similar design which was performed in 11 US centers. A total of 251 patients (glatiramer acetate injection: n = 125; placebo: n = 126) were enrolled. The primary outcome measure was the Mean 2-Year Relapse Rate. Table 4 presents the values of this outcome for the intent-to-treat population, as well as several secondary measures:
  • In both studies, glatiramer acetate exhibited a clear beneficial effect on relapse rate, and it is based on this evidence that glatiramer acetate is considered effective.
  • In Study 3, 481 patients who had recently (within 90 days) experienced an isolated demyelinating event and who had lesions typical of multiple sclerosis on brain MRI were randomized to receive either glatiramer acetate injection 20 mg per mL (n = 243) or placebo (n = 238). The primary outcome measure was time to development of a second exacerbation. Patients were followed for up to three years or until they reached the primary endpoint. Secondary outcomes were brain MRI measures, including number of new T2 lesions and T2 lesion volume.
  • Time to development of a second exacerbation was significantly delayed in patients treated with glatiramer acetate injection compared to placebo (Hazard Ratio = 0.55; 95% confidence interval 0.40 to 0.77; Figure 1). The Kaplan-Meier estimates of the percentage of patients developing a relapse within 36 months were 42.9% in the placebo group and 24.7% in the glatiramer acetate group.
  • Patients treated with glatiramer acetate injection demonstrated fewer new T2 lesions at the last observation (rate ratio 0.41; confidence interval 0.28 to 0.59; p < 0.0001). Additionally, baseline-adjusted T2 lesion volume at the last observation was lower for patients treated with glatiramer acetate injection (ratio of 0.89; confidence interval 0.84 to 0.94; p = 0.0001).
  • Study 4 was a multinational study in which MRI parameters were used both as primary and secondary endpoints. A total of 239 patients with RRMS (glatiramer acetate: n = 119; and placebo: n = 120) were randomized. Inclusion criteria were similar to those in the second study with the additional criterion that patients had to have at least one Gd-enhancing lesion on the screening MRI. The patients were treated in a double-blind manner for nine months, during which they underwent monthly MRI scanning. The primary endpoint for the double-blind phase was the total cumulative number of T1 Gd-enhancing lesions over the nine months. Table 5 summarizes the results for the primary outcome measure monitored during the trial for the intent-to-treat cohort.
  • Figure 2 displays the results of the primary outcome on a monthly basis.
  • Arrayn- Glatiramer Acetate Injection 40 mg per mL three times per week:
  • The primary outcome measure was the total number of confirmed relapses (persistence of neurological symptoms for at least 48 hours confirmed on examination with objective signs). The effect of glatiramer acetate on several magnetic resonance imaging (MRI) variables, including number of new or enlarging T2 lesions and number of enhancing lesions on T1-weighted images, was also measured at months 6 and 12.
  • Table 6 presents the results for the intent-to-treat population.
  • Glatiramer Acetate Injection is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution in a 1 mL single-dose, prefilled syringe with fixed u00bd inch 29 gauge needle supplied as:
  • Store glatiramer acetate injection refrigerated at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). If needed, the patient may store glatiramer acetate injection at room temperature, 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F), for up to one month, but refrigeration is preferred. Avoid exposure to higher temperatures or intense light. Do not freeze glatiramer acetate injection. If a glatiramer acetate syringe freezes, it should be discarded.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Immediate Post-Injection Reaction:
  • Chest Pain:
  • Lipoatrophy and Skin Necrosis at Injection Site:
  • Pregnancy:u00a0n- [see ]
  • Lactation: n- [see ]
  • Instructions for Use:
  • Storage Conditions:
  • Glatiramer Acetate Injection(gla tiru2032 a mer asu2032 e tate)for subcutaneous use
  • Read this Patient Information before you start using glatiramer acetate injection and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
  • What is glatiramer acetate injection?
  • Glatiramer acetate injection is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • It is not known if glatiramer acetate injection is safe and effective in children under 18 years of age.
  • Who should not use glatiramer acetate injection?
  • What should I tell my doctor before using glatiramer acetate injection?
  • Before you use glatiramer acetate injection, tell your doctor if you:
  • Tell your doctor about all the medicines you take
  • Glatiramer acetate injection may affect the way other medicines work, and other medicines may affect how glatiramer acetate injection works.
  • Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.
  • How should I use glatiramer acetate injection?
  • What are the possible side effects of glatiramer acetate injection?
  • Glatiramer acetate injection may cause serious side effects, including:
  • The most common side effects of glatiramer acetate injection include:
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of glatiramer acetate injection. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store glatiramer acetate injection?
  • Keep glatiramer acetate injection and all medicines out of the reach of children.
  • General information about the safe and effective use of glatiramer acetate injection.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use glatiramer acetate injection for a condition for which it was not prescribed. Do not give glatiramer acetate injection to other people, even if they have the same symptoms as you have. It may harm them.
  • This Patient Information Leaflet summarizes the most important information about glatiramer acetate injection. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about glatiramer acetate injection that is written for health professionals.
  • For more information, go to www.glatirameracetate.com or call 1-844-695-2667.
  • What are the ingredients in glatiramer acetate injection?
  • Active ingredient:
  • Inactive ingredients:
  • u00a0
  • u00a0
  • Instructions for UseGlatiramer Acetate Injectionn- (gla tiru2032 a mer asu2032 e tate)n- 20 mg/mLn- for subcutaneous use
  • For subcutaneous injection only.
  • Do not
  • Do not
  • Do not
  • You should receive your first dose of glatiramer acetate injection
  • Glatiramer acetate injection comes in a 20 mg prefilled syringe with needle attached. How often a dose is given depends on the product strength that is prescribed. Your doctor will prescribe the correct dose for you.
  • Instructions for using your glatiramer acetate 20 mg prefilled syringe:
  • How do I inject glatiramer acetate injection?
  • Arrayn- See Figure A.
  • Arrayn- See
  • Figure B.
  • Arrayn- Step 3
  • Arrayn- See Figure C.
  • See the injection areas you should use on your body. Talk with your doctor about the injection areas that are best for you.
  • Arrayn- Step 5
  • Arrayn- Step 6
  • Arrayn- See Figure E.
  • Arrayn- See Figure F.
  • Arrayn- Step 9
  • Arrayn- Step 10
  • To inject the medicine, hold the syringe steady and slowly push down the plunger. n
  • Arrayn- Step 11
  • After you have injected all of the medicine, pull the needle straight out. n
  • Arrayn- See Figure K.
  • Arrayn- Step 13
  • This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabad 500 043India
  • Code No.: AP/DRUGS/10/2012n
  • Revised: 2/2020GL:GLATIJ:R7389029LEA-019456-05
  • NDC 0378-6960-93
  • Glatiramer Acetaten- Injectionn- 20 mg/mLu00a0u00a0u00a0u00a0u00a0ONCE DAILY
  • For Subcutaneous Injection Only
  • Rx only
  • Contains 30 Single-Dose PRE-FILLED Syringesn- with fixed u00bd inch 29 gauge needles
  • To be dispensed as a unit package in carton.
  • Usual Dosage:
  • Each 1 mL unit-of-use pre-filled syringen- contains:
  • Storage Conditions: KEEP REFRIGERATEDn- (2u00b0 to 8u00b0C/36u00b0 to 46u00b0F) AND PROTECTu00a0FROM LIGHT.
  • Keep this and all medication out of the reach of children.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in IndiaCode No.: AP/DRUGS/10/2012
  • GL6960:93:30C:R5
  • Mylan.com
  • 390026

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